WORLD TRADE
G/TBT/N/CAN/223
9 January 2008
ORGANIZATION
(08-0089)
Committee on Technical Barriers to Trade
Original: English/
French
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1.
Member to Agreement notifying: CANADA
If applicable, name of local government involved (Articles 3.2 and 7.2):
2.
Agency responsible: Department of Health
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:
Canadian Enquiry Point
200-270 Albert Street
Ottawa, Ontario
Canada, K1P 6N7
Tel.: +1 613 238 3222
Fax.: +1 613 569 7808
E-mail: enquirypoint@scc.ca
3.
Notified under Article 2.9.2 [ X ], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:
4.
Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable): Prescription status of
medicinal ingredients for human use (ICS: 11.120)
5.
Title, number of pages and language(s) of the notified document: Proposed Amendment
to the Food and Drug Regulations (Project No. 1583 — Schedule F) (4 pages, in English
and French)
6.
Description of content: This notification announces the availability of a letter that
provides an opportunity to comment on the proposed addition of six medicinal ingredients
to Part I of Schedule F to the Food and Drug Regulations.
Description of the medicinal ingredients:
1. Aprepitant and its derivatives is a neurokinin 1 (NK1) receptor antagonist used
for the prevention of nausea and vomiting associated with cancer treatment.
Aprepitant should be administered under the supervision of a practitioner
experienced in cancer therapy. The patient may require treatment with other drugs
and routine laboratory monitoring. Aprepitant may cause undesirable or severe side
effects at normal therapeutic dosage levels.
G/TBT/N/CAN/223
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2. Daptomycin is a cyclic lipopeptide antibacterial agent used for the treatment of
bacterial infections, including serious skin infections and certain blood stream
infections. Daptomycin must be administered by the intravenous route. Direct
supervision by a practitioner and routine laboratory monitoring are required.
Daptomycin may cause undesirable or severe side effects at normal therapeutic
dosage levels.
3. Duloxetine and its salts is a balanced serotonin and norepinephrine reuptake
inhibitor. Duloxetine is used to treat major depressive disorder and for the
management of neuropathic pain associated with diabetic peripheral neuropathy.
The safe and effective use of duloxetine requires that an accurate diagnosis of
depression or neuropathic pain be made by the practitioner. The practitioner must
provide individualized dosage and other instructions, and maintain close medical
supervision and patient follow-up throughout treatment.
4. Maraviroc is a member of a therapeutic class called CCR5 antagonists used for the
treatment of HIV-1 (Human Immunodeficiency Virus type 1) infection. Maraviroc
is administered in combination with other anti-HIV medications. Individualized
instructions or direct supervision by a practitioner are required. The patient may
also require treatment with other drugs and routine laboratory monitoring.
5. Paliperidone and its salts and its derivatives is an antipsychotic drug used in the
treatment of schizophrenia. Diagnosis of schizophrenia requires a practitioner
specialized in the area of psychotic disorders. The practitioner must provide
individualized dosage and other instructions, and maintain close medical
supervision and patient follow-up throughout treatment. Paliperidone may cause
undesirable or severe side effects at normal therapeutic dosage levels.
6. Ziprasidone and its salts is an antipsychotic drug used in the treatment of
schizophrenia and related psychotic disorders. Diagnosis of schizophrenia requires
a practitioner specialized in the area of psychotic disorders, who must then also
decide on the most appropriate forms of treatment. The practitioner must provide
individualized dosage and other instructions, and maintain close medical
supervision and patient follow-up throughout treatment.
The degree of regulatory control afforded by Schedule F (prescription drug) status coincides
with the risk factors associated with each medicinal ingredient. Oversight by a practitioner
is necessary to ensure that appropriate risk/benefit information is considered before the drug
containing the medicinal ingredient is administered and that the drug therapy is properly
monitored.
Schedule F is a list of medicinal ingredients, the sale of which is controlled under sections
C.01.041 to C.01.049 of the Food and Drug Regulations. Part I of Schedule F lists
ingredients that require a prescription for human use and for veterinary use. Part II of
Schedule F lists ingredients that require a prescription for human use, but do not require a
prescription for veterinary use if so labelled or if in a form unsuitable for human use.
7.
Objective and rationale, including the nature of urgent problems where applicable:
Protection of human health
G/TBT/N/CAN/223
Page 3
8.
Relevant documents: Therapeutic Products Directorate (TPD) website
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/notice-avis/index_e.htm
Project No. 1583, letter posted: 19 December 2007
9.
Proposed date of adoption:
Normally within 6 to 8 months from the
posting of the letter on the TPD website.
Proposed date of entry into force:
On the date the measure is adopted.
10.
Final date for comments: 3 March 2008
11.
Texts available from: National enquiry point [ X ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:
The electronic version of Project No. 1583 can be downloaded at:
http://www.hc-sc.gc.ca/dhp-mps/prodpharma/legislation/acts-lois/noticeavis/project_projet_1583_e.html